SKYLIGHT 4™ study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily
Pooled analyses will also be presented from SKYLIGHT 1™ and SKYLIGHT 2™ studies of fezolinetant, Astellas’ investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause
TOKYO, October 12, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 52-week results from the Phase 3 SKYLIGHT 4™ clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. The results will be featured in an oral presentation October 13 at The North American Menopause Society Annual Meeting. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2
SKYLIGHT 4 results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily. Safety analyses demonstrated that both endometrial hyperplasia and endometrial malignancy were within pre-specified limits for fezolinetant-treated patients; reported treatment-emergent adverse events (TEAEs) were generally mild or moderate in severity; and headache and COVID-19 were the most common TEAEs, with similar incidences for fezolinetant and placebo. The frequency of elevated liver enzymes was low across groups, and elevations were generally asymptomatic, isolated, transient and resolved on treatment or soon after study drug discontinuation.
“There is an unmet need for safe and effective nonhormonal treatment options for VMS associated with menopause, which can adversely impact daily quality of life,” said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology. “The SKYLIGHT 4 study results demonstrate the long-term safety and tolerability of fezolinetant, providing further support for its potential use as a treatment for VMS.”
In addition, pooled efficacy data from SKYLIGHT 1™ and SKYLIGHT 2™ evaluating early response to fezolinetant, its impact on sleep and treatment response analyzed by race will be presented.
“Results of the SKYLIGHT 4 study and the pooled analyses from the SKYLIGHT 1 and 2 studies provide further insights into the safety and effectiveness of fezolinetant,” said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. “Through our clinical development program, we are excited to further characterize the clinical profile of fezolinetant for women who experience hot flashes as part of menopause."
Fezolinetant is an investigational selective neurokinin 3 (NK3) receptor antagonist and is not approved for use anywhere in the world. New Drug and Marketing Authorization applications for fezolinetant are under review in the U.S. and Europe, respectively. If approved, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.
Astellas will also present three abstracts examining the association between VMS and weight gain, sleep quality and work productivity.
Following are all of Astellas’ presentations at NAMS 2022:
SKYLIGHT Data at NAMS
| Abstract | Presentation Details |
| A phase 3, randomized, placebo-controlled, double-blind study to investigate the long-term safety and tolerability of fezolinetant in women seeking treatment for vasomotor symptoms associated with menopause (SKYLIGHT 4) – Abstract S-11 | Genevieve Neal-Perry, M.D., Ph.D. Oral Presentation October 13, 5:30-5:45 p.m. EDT |
| Early response with fezolinetant treatment of moderate-to-severe vasomotor symptoms associated with menopause: pooled data from two randomized Phase 3 studies – Abstract P-73 | Marla Shapiro, M.D.C.M, M.H.Sc. Poster Session October 13, 6:15-7:15 p.m. EDT |
| Effect of fezolinetant treatment on patient-reported sleep disturbance: pooled data from two Phase 3 studies in women with moderate-to-severe vasomotor symptoms associated with menopause – Abstract P-74 | Marla Shapiro, M.D.C.M, M.H.Sc. Poster Session October 13, 6:15-7:15 p.m. EDT |
| Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause: efficacy in women stratified by race using pooled data from two Phase 3 studies – Abstract P-53 | Genevieve Neal-Perry, M.D., Ph.D. Poster Session October 13, 6:15-7:15 p.m. EDT |
Astellas VMS Data at NAMS
| Presentation Title | Presentation Details |
| Association between vasomotor symptom frequency and weight gain in women enrolled in the study of women’s health across the nation (SWAN) – Abstract S-24 | Carolyn Gibson, Ph.D., M.P.H. Oral Presentation October 14, 4:45-5 p.m. EDT |
| Association between vasomotor symptom severity and sleep outcomes in a survey of US women with symptoms of menopause – Abstract P-16 | Barbara DePree, M.D. Poster Session October 13, 6:15-7:15 p.m. EDT |
| Association between severity of vasomotor symptoms of menopause and work productivity in a survey of US women – Abstract P-15 | Barbara DePree, M.D. Poster Session October 13, 6:15-7:15 p.m. EDT |
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